Clinical Research Support

Clinical Trials Education Office (CTEO)

National Protocol Registration

U.S Public Law 110-85, along with the International Committee on Medical Journal Editors (ICMJE signatories include: New England Journal of Medicine and Journal of the American Medical Association), require registration of clinical trials on the National Institute of Health (NIH) publicly-accessible database, clinicaltrials.gov. However, the FDA and the ICMJE each have their own registration requirements which can cause some confusion. Outlined below are the registration requirements:

FDA Clinical Trials Registration:
The FDA has the following registration requirements:

All clinical trials for drugs, devices, and biologics with the exception of Phase I drug trials and small device feasibility studies, must be registered within 21 days after the first participant is enrolled.
Results of trials must be registered upon the completion of the primary aim of the study.
Information provided in the registration must be updated at least annually or as the information changes.

ICMJE Clinical Trial Registration:
The ICMJE has the following registration requirements:

Any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome must be registered before the first participant is enrolled.
EFFECTIVE July 1, 2008 this includes Phase I and pharmaco-kinetic trials
Information provided in the registration must be updated every 6 months.

Posting Basic Results

September 2008: The FDA expanded its requirements regarding posting clinical trials on clinicaltrials.gov to include a posting of basic study results. The following, from the clinicaltrials.gov website outlines the expectations around this basic results posting:

FDA Amendments Act (FDAAA), Section 801: “Basic Results” Provisions
[Source: Pub L. 110-85, Sec. 801, adding new 42 U.S.C. 282(j)(3)(C)]‘‘

(C) BASIC RESULTS.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act:‘‘

(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.‘‘

(ii) PRIMARY AND SECONDARY OUTCOMES.—The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.‘‘

(iii) POINT OF CONTACT.—A point of contact for scientific information about the clinical trial results.‘‘

(iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.

Upcoming FDA Posting Requirements

March 2009: Posting serious adverse events/most frequent adverse events. These results will likely require some sort of narrative summary.

March 2010: Posting expanded study results including a lay summary of the resutls, the protocol and a description of the quality assurance and quality control procedures used through out the study.

Registration FAQ's

Who is responsible for the registration?
The sponsor of the drug or device clinical trial, as defined under the FDA regulation, is responsible for registering the trial. However, the sponsor, at their discretion, can delegate the principal investigator as the "responsible party".

For PI-initiated, in-house trials, the Overall Principal Investigator is responsible for the registration as he/she is considered the sponsor..

How do I know whether or not I should register my trial?
If you are working on a sponsored trial, contact the sponsor to verify registration responsibility.

For PI-initiated, in-house trials, we are encouraging investigators to register ALL trials regardless of the Phase to ensure that all requirements (both ICMJE and FDA) are met.

How do I register my trial?
Before registering your clinical trial, please contact the registration administrator. The registration administrator will ensure that you are set up as a user of the registration website with a user name and password.

Once you have received confirmation of your user name and password, log on to register.clinicaltrials.gov and enter the required data. The register.clinicaltrials.gov website has detailed instructions on each required data element and how to complete the registration.

Who is responsible for updating the information?
The responsibility of keeping the information current and updated lies with the sponsor. For PI-initated, in-house trials, the Overall Investigator should go in and update the information every 6 months or withing 30 days of any recruitment status changes or study completion. As a courtesy, the clinicaltrials.gov Protocol Registration System (PRS) will send out email reminders every 6 months.

Click here for instructions on updating trial information at clinicaltrials.gov.

Who should I contact if I have any questions or need to obtain an account on register.clinicaltrials.gov?
Contact the registration administrator at cteo@dfci.harvard.edu or 617-582-8310.

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Clinical Research Support Clinical Trials Education Office (CTEO) National Protocol Registration U.S Public Law 110-85, along with the International Committee on Medical Journal Editors (ICMJE signatories include: New England Journal of Medicine and Journal of the American Medical Association), require registration of clinical trials on the National Institute of Health (NIH) publicly-accessible database, clinicaltrials.gov. However, the FDA and the ICMJE each have their own registration requirements which can cause some confusion. Outlined below are the registration requirements: FDA Clinical Trials Registration: The FDA has the following registration requirements: All clinical trials for drugs, devices, and biologics with the exception of Phase I drug trials and small device feasibility studies, must be registered within 21 days after the first participant is enrolled. Results of trials must be registered upon the completion of the primary aim of the study. Information provided in the registration must be updated at least annually or as the information changes. ICMJE Clinical Trial Registration: The ICMJE has the following registration requirements: Any human research project that prospectively assigns human subjects to an intervention or comparison group to study the relationship between a medical intervention and a health outcome must be registered before the first participant is enrolled. EFFECTIVE July 1, 2008 this includes Phase I and pharmaco-kinetic trials Information provided in the registration must be updated every 6 months. Posting Basic Results *September 2008:* The FDA expanded its requirements regarding posting clinical trials on clinicaltrials.gov to include a posting of basic study results. The following, from the clinicaltrials.gov website outlines the expectations around this basic results posting: FDA Amendments Act (FDAAA), Section 801: “Basic Results” Provisions [Source: Pub L. 110-85, Sec. 801, adding new 42 U.S.C. 282(j)(3)(C)]‘‘ (C) BASIC RESULTS.—Not later than 1 year after the date of the enactment of the Food and Drug Administration Amendments Act of 2007, the Secretary shall include in the registry and results data bank the following elements for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section 351 of this Act and devices that are cleared under section 510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 520(m) of such Act:‘‘ (i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.‘‘ (ii) PRIMARY AND SECONDARY OUTCOMES.—The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.‘‘ (iii) POINT OF CONTACT.—A point of contact for scientific information about the clinical trial results.‘‘ (iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial. Upcoming FDA Posting Requirements March 2009: Posting serious adverse events/most frequent adverse events. These results will likely require some sort of narrative summary. March 2010: Posting expanded study results including a lay summary of the resutls, the protocol and a description of the quality assurance and quality control procedures used through out the study. Registration FAQ's Who is responsible for the registration? The sponsor of the drug or device clinical trial, as defined under the FDA regulation, is responsible for registering the trial. However, the sponsor, at their discretion, can delegate the principal investigator as the "responsible party". For PI-initiated, in-house trials, the Overall Principal Investigator is responsible for the registration as he/she is considered the sponsor.. How do I know whether or not I should register my trial? If you are working on a sponsored trial, contact the sponsor to verify registration responsibility. For PI-initiated, in-house trials, we are encouraging investigators to register ALL trials regardless of the Phase to ensure that all requirements (both ICMJE and FDA) are met. How do I register my trial? Before registering your clinical trial, please contact the registration administrator. The registration administrator will ensure that you are set up as a user of the registration website with a user name and password. Once you have received confirmation of your user name and password, log on to register.clinicaltrials.gov and enter the required data. The register.clinicaltrials.gov website has detailed instructions on each required data element and how to complete the registration. Who is responsible for updating the information? The responsibility of keeping the information current and updated lies with the sponsor. For PI-initated, in-house trials, the Overall Investigator should go in and update the information every 6 months or withing 30 days of any recruitment status changes or study completion. As a courtesy, the clinicaltrials.gov Protocol Registration System (PRS) will send out email reminders every 6 months. Click here for instructions on updating trial information at clinicaltrials.gov. Who should I contact if I have any questions or need to obtain an account on register.clinicaltrials.gov? Contact the registration administrator at cteo@dfci.harvard.edu or 617-582-8310.	Office for Human Research Studies (OHRS) Quality Assurance Office for Clinical Trials (QACT) Clinical Investigations Leadership Committee (CLC) Clinical Trials Education Office (CTEO) Education Services Contacts Clinical Research Unit (CRU) Protocol Review and Monitoring System (PRMS)
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